Psychological DistressNCT05899998
Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience
A study testing Bright IDEAS in people with Psychological Distress and Quality of Life, run by Children's Hospital Los Angeles at 1 site in United States.
Trial summary
The goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright IDEAS problem solving skills training for parents of children in palliative care. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Psychological Distress, Quality of Life
- What is being tested?
- Bright IDEAS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2023to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Parents or legal guardians of male and female children (ages 0-21) of any race or ethnicity and of any underlying medical diagnosis
- Child received at least one consult from the Comfort and Palliative Care team within the past month
- One parent or primary caregiver per child
- Able to speak, read, and write English or Spanish, and give informed consent
- Children 8-17 years of age whose primary caregiver has consented to participate
- Able to read and write English or Spanish and assent
Who cannot join
- Parent age less than 18 years old
- Concurrent enrollment on another research study testing psychoeducational interventions for parents and/or patients
- Child has an estimated life expectancy of less than 4 months at time of study recruitment
- Child
- Parent refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Los Angeles
Los Angeles, California, 90027
About this study
The goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright IDEAS problem solving skills training for parents of children in palliative care. The main questions it aims to answer are:
- Is bright IDEAS problem solving skills training feasible and acceptable for parents of children referred to pediatric palliative care?
- Does bright IDEAS reduce psychological distress in parents compared to parents receiving standard palliative care support?
Read more
Participants will:
- Participate in 6-8 sessions of the bright IDEAS program.
- Complete self report measures of psychological distress and well being.
If there is a comparison group: Researchers will compare bright IDEAS to standard palliative care support.
- Conditions
- Psychological Distress, Quality of Life
- Being tested
- Bright IDEAS
- Keywords
- Depressive Symptoms, Anxiety, Post-Traumatic Stress
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bright IDEASBehavioural
Bright IDEAS® (Identify, Define, Evaluate, Act, See) is a problem-solving skills training program that was originally developed to alleviate distress in caregivers of children recently diagnosed with cancer. Intervention materials include instructor and user manuals, a brochure, and worksheets to be completed by the parent caregiver, initially with the help of the interventionist and then with increasing independence.
| Study group | Role | What they receive |
|---|---|---|
| Bright IDEAS | Experimental | Not described Receives: Behavioral: Bright IDEAS |
| Standard of Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Bright IDEAS for parents
Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.
Measured: Baseline to 12 weeks
Parent Problem-Solving skills
Social Problem-Solving Inventory-Revised Short Form. This is a a 25-item self-report instrument that measures five dimensions of problem-solving (positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style) using a five-point Likert scale (0 = "Not at All True of Me" to 4 = "Extremely True of Me"). Summary scores for each subscale as well as a Total Raw Score range from 0-20. Higher scores indicate better self-reported problem-solving skills.
Measured: Baseline to 16 weeks
Anxiety symptoms
PROMIS® Anxiety Short Form-v1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of anxiety.
Measured: Baseline to 16 weeks
Depression symptoms
PROMIS® Depression Short Form-v 1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of depressive symptoms.
Measured: Baseline to 16 weeks
Traumatic stress symptoms
Abbreviated Posttraumatic Checklist -Civilian Version (PCL-6). This is a 6-item self-report screening measure empirically derived from the PCL-C, consisting of the most highly responsive items from each of the reexperiencing, avoidance, and hyperarousal symptom domains of the PCL-C and has previously been used with parents of children with serious illness. The PCL-6 uses a five-point Likert scale (0 = "Not at all" to 5 = "Extremely"), with total scores ranging from 6-30. Higher scores indicate higher levels of traumatic stress symptoms.
Measured: Baseline to 16 weeks
Secondary outcomes (4)
Parent Wellbeing
CarerQoL. The CarerQOL evaluates care-related quality of life and incorporates caregiving burden as well as positive effects of caregiving. It consists of 7 items related to caregiving burdens, fulfillment, or support that participants self-rate on a 3-point qualitative scale ("No", "Some" or "A lot of") as well as 1 item in which the respondent rates their current overall happiness on a 10-point visual analog scale with higher scores corresponding to higher positive affect (0 = "completely unhappy" to 10 = "completely happy"). The measure will be slightly adapted to clarify reference to the child as the care receiver.
Measured: Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 0-7 years old
PROMIS® Early Childhood Parent Report Global Health 8a contains 8 items, assessing global health and development. All items use a 5-point Likert scale (1 = Poor to 5 = Excellent). Total raw sum scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate better reported wellbeing.
Measured: Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 8+ years old
PROMIS® Parent Proxy Scale v1.0 Global Health 7+2. This measure contains 9 items in total, including 7 items assessing global health (physical and mental wellbeing), and 1 item each related to fatigue and pain burden. All items are completed on a 5-point Likert scale (anchors are 1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Total raw sum scores for global health range from 7-35 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Raw scores for the fatigue and pain items each range from 1-4 and are each separately converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate better reported wellbeing and lower fatigue and pain, respectively.
Measured: Baseline to 16 weeks
Child Quality of Life (QoL) Child Self-Report
Participating parents' child (ages 8+) who are medically and cognitively able will be invited to complete the PROMIS® Pediatric Scale v1.0 Global Health 7+2 to measure self-reported quality of life. This measure contains 9 items in total, including 7 items assessing global health (physical and mental wellbeing), and 1 item each related to fatigue and pain burden. All items are completed on a 5-point Likert scale (anchors are 1= Poor to 5 = Excellent, or 1 = Never to 5 = Always or Almost always, depending on the domain). Total raw sum scores for global health range from 7-35 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Raw scores for the fatigue and pain items each range from 1-4 and are each separately converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate better reported wellbeing and lower fatigue and pain, respectively.
Measured: Baseline to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start8 Aug 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bemis, Heather, Children's Hospital Los Angeles
- Investigators
- Heather Bemis, PhD, Principal investigator, Children's Hospital Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899998
- Sponsor's protocol ID
- CHLA-23-00162
- Status last verified
- Dec 2025
- First submitted
- 26 May 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bright IDEAS for Pediatric Palliative Care: A Problem-Solving Skills Intervention to Empower Parent Resilience
- ClinicalTrials.gov ID
- NCT05899998
- Acronym / sponsor ID
- CHLA-23-00162
- Conditions
- Psychological Distress, Quality of Life
- Keywords
- Depressive Symptoms, Anxiety, Post-Traumatic Stress
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Children's Hospital Los AngelesUniversity, hospital or other
- Study start
- 8 Aug 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this or clinical trial is to test in the feasibility, acceptability and preliminary efficacy of the bright IDEAS problem solving skills training for parents of children in palliative care. The main questions it aims to answer are:
- Is bright IDEAS problem solving skills training feasible and acceptable for parents of children referred to pediatric palliative care?
- Does bright IDEAS reduce psychological distress in parents compared to parents receiving standard palliative care support?
Participants will:
- Participate in 6-8 sessions of the bright IDEAS program.
- Complete self report measures of psychological distress and well being.
If there is a comparison group: Researchers will compare bright IDEAS to standard palliative care support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bright IDEAS | Experimental | Behavioral: Bright IDEAS |
| Standard of Care | No intervention | – |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Parents or legal guardians of male and female children (ages 0-21) of any race or ethnicity and of any underlying medical diagnosis
- Child received at least one consult from the Comfort and Palliative Care team within the past month
- One parent or primary caregiver per child
- Able to speak, read, and write English or Spanish, and give informed consent
- Children 8-17 years of age whose primary caregiver has consented to participate
Key exclusion criteria (5 listed)
- Parent age less than 18 years old
- Concurrent enrollment on another research study testing psychoeducational interventions for parents and/or patients
- Child has an estimated life expectancy of less than 4 months at time of study recruitment
- Child
- Parent refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bright IDEASBright IDEAS® (Identify, Define, Evaluate, Act, See) is a problem-solving skills training program that was originally developed to alleviate distress in caregivers of children recently diagnosed with cancer. Intervention materials include instructor and user manuals, a brochure, and worksheets to be completed by the parent caregiver, initially with the help of the interventionist and then with increasing independence. | Behavioural | Bright IDEAS |
Primary outcome
Feasibility of Bright IDEAS for parents
Time frame: Baseline to 12 weeks
Percent eligible participants who consent/assent to participate and Number of sessions completed by enrolled participants.
Parent Problem-Solving skills
Time frame: Baseline to 16 weeks
Social Problem-Solving Inventory-Revised Short Form. This is a a 25-item self-report instrument that measures five dimensions of problem-solving (positive problem orientation, negative problem orientation, rational problem-solving style, impulsive/carelessness style, and avoidant style) using a five-point Likert scale (0 = "Not at All True of Me" to 4 = "Extremely True of Me"). Summary scores for each subscale as well as a Total Raw Score range from 0-20. Higher scores indicate better self-reported problem-solving skills.
Anxiety symptoms
Time frame: Baseline to 16 weeks
PROMIS® Anxiety Short Form-v1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of anxiety.
Depression symptoms
Time frame: Baseline to 16 weeks
PROMIS® Depression Short Form-v 1.0 8a. This self-report measure includes includes 8 items on which participants respond using a 5-point scale (1 = "Never" to 5 = "Always"). Total raw scores range from 8-40 and are converted to standardized T-scores with a mean of 50 and standard deviation of 10. Higher scores indicate higher levels of depressive symptoms.
Traumatic stress symptoms
Time frame: Baseline to 16 weeks
Abbreviated Posttraumatic Checklist -Civilian Version (PCL-6). This is a 6-item self-report screening measure empirically derived from the PCL-C, consisting of the most highly responsive items from each of the reexperiencing, avoidance, and hyperarousal symptom domains of the PCL-C and has previously been used with parents of children with serious illness. The PCL-6 uses a five-point Likert scale (0 = "Not at all" to 5 = "Extremely"), with total scores ranging from 6-30. Higher scores indicate higher levels of traumatic stress symptoms.
4 secondary outcomes
Parent Wellbeing
Time frame: Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 0-7 years old
Time frame: Baseline to 16 weeks
Child Quality of Life (QoL) Parent Proxy 8+ years old
Time frame: Baseline to 16 weeks
Child Quality of Life (QoL) Child Self-Report
Time frame: Baseline to 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Bemis, PhD principal investigator
Children's Hospital Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bright IDEAS in people with Psychological Distress and Quality of Life, run by Children's Hospital Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Bright IDEAS for parents (time frame: Baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.